LABETALOL HYDROCHLORIDE

Product NDC
67296-2156
11-digit product format
672962156
Labeler code
67296
Product ID
67296-2156_45d26aad-d9c8-19f8-e063-6394a90a63c3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Labetalol Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Redpharm Drug
Application
ANDA211953
Marketing category
ANDA
Marketing start
2021-08-18
Substance
LABETALOL HYDROCHLORIDE
Active strength
100 mg/1
Pharmacologic classes
Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
LABETALOL HYDROCHLORIDE
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LABETALOL HYDROCHLORIDE100 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii1GEV3BAW9J
Rxcui896758

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
baf61d8c-dcd3-e95d-db84-9bb0d0a2b77fProduct name220220311
759f1c41-9262-4238-8cee-33988631aaf4Product name520220217
3b2edbb4-6acf-4674-b1d9-22addd3dad21Product name120210527

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67296-2156-1LABETALOL HYDROCHLORIDE15 in 1 BOTTLETABLET, FILM COATED154

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67296-2156LABETALOL HYDROCHLORIDE TABLET, FILM COATED [REDPHARM DRUG]1Current NDC, 1 package rows20250410_32525ed4-3cca-2b99-e063-6294a90a6c66.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
896758labetalol HCl 100 MG Oral TabletPSN32525ed4-3cca-2b99-e063-6294a90a6c664
896758labetalol hydrochloride 100 MG Oral TabletSCD32525ed4-3cca-2b99-e063-6294a90a6c664

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
67296-2156-16729621560115 TABLET, FILM COATED in 1 BOTTLE (67296-2156-1) 2021-08-18NoNoCurrent